Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 30, 2015 | |
Document Information [Line Items] | ||
Entity Registrant Name | OPGEN INC | |
Entity Central Index Key | 1,293,818 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | OPGN | |
Entity Common Stock, Shares Outstanding | 12,539,704 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,015 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets | ||
Cash and cash equivalents | $ 11,187,129 | $ 749,517 |
Accounts receivable, net | 553,938 | 503,983 |
Inventory, net | 1,155,488 | 369,742 |
Prepaid expenses and other current assets | 538,312 | 90,233 |
Total current assets | 13,434,867 | 1,713,475 |
Property and equipment, net | 1,021,971 | 587,956 |
Deferred IPO issuance costs | 0 | 296,041 |
Intangible assets, net | 1,955,769 | 0 |
Goodwill | 291,747 | 0 |
Other noncurrent assets | 293,135 | 57,459 |
Total assets | 16,997,489 | 2,654,931 |
Current liabilities | ||
Accounts payable | 1,274,657 | 1,160,081 |
Accrued compensation and benefits | 840,637 | 423,099 |
Accrued liabilities | 1,232,328 | 993,657 |
Deferred revenue | 158,860 | 339,171 |
Short-term notes payable | 1,250 | 1,505,000 |
Current maturities of long-term capital lease obligations | 227,049 | 100,499 |
Short-term convertible notes, net of discounts | 0 | 1,500,000 |
Total current liabilities | 3,734,781 | 6,021,507 |
Note payable | 1,000,000 | 0 |
Long-term capital lease obligations and other noncurrent liabilities | 317,854 | 134,149 |
Total liabilities | $ 5,052,635 | 6,155,656 |
Commitments and contingencies (Note 10) | ||
Redeemable convertible preferred stock | ||
Redeemable convertible preferred stock | $ 0 | 4,564,899 |
Stockholders' equity (deficit) | ||
Common stock, $.01 par value; 200,000,000 shares authorized; 12,539,704 and 493,178 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | 125,397 | 4,932 |
Additional paid-in capital | 121,216,140 | 88,701,737 |
Accumulated other comprehensive loss | (49) | 0 |
Accumulated deficit | (109,396,634) | (96,772,293) |
Total stockholders' equity (deficit) | 11,944,854 | (8,065,624) |
Total liabilities, redeemable preferred stock and stockholders' equity (deficit) | 16,997,489 | 2,654,931 |
Series A Convertible Redeemable Preferred Stock | ||
Redeemable convertible preferred stock | ||
Redeemable convertible preferred stock | $ 0 | $ 4,564,899 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 12,539,704 | 493,178 |
Common stock, shares outstanding | 12,539,704 | 493,178 |
Series A Convertible Redeemable Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 6,000,000 | 6,000,000 |
Preferred stock, shares issued | 0 | 3,999,864 |
Preferred stock, shares outstanding | 0 | 3,999,864 |
Preferred stock, liquidation preference | $ 0 | $ 7,999,728 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Other Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue | ||||
Product sales | $ 929,241 | $ 268,854 | $ 1,432,592 | $ 841,567 |
Laboratory services | 23,765 | 88,190 | 87,201 | 379,339 |
Collaboration revenue | 27,780 | 477,780 | 308,340 | 1,783,340 |
Total revenue | 980,786 | 834,824 | 1,828,133 | 3,004,246 |
Cost of products sold (excluding depreciation and amortization) | 562,694 | 101,425 | 712,016 | 276,831 |
Cost of services (excluding depreciation and amortization) | 46,634 | 129,120 | 191,738 | 336,616 |
Total costs of sales (excluding depreciation and amortization) | 609,328 | 230,545 | 903,754 | 613,447 |
Gross profit | 371,458 | 604,279 | 924,379 | 2,390,799 |
Operating expenses | ||||
Research and development | 1,724,127 | 1,029,650 | 3,741,247 | 3,075,420 |
General and administrative | 1,610,828 | 555,444 | 3,687,313 | 1,590,085 |
Sales and marketing | 979,681 | 459,064 | 2,815,976 | 1,486,801 |
Depreciation and amortization | 185,177 | 141,060 | 392,404 | 461,432 |
Transaction expenses | 525,596 | 0 | 525,596 | 0 |
Total operating expenses | 5,025,409 | 2,185,218 | 11,162,536 | 6,613,738 |
Operating loss | (4,653,951) | (1,580,939) | (10,238,157) | (4,222,939) |
Other income (expense) | ||||
Interest income | 2,513 | 37 | 9,675 | 120 |
Interest expense | (17,482) | (32,331) | (1,746,853) | (47,468) |
Change in fair value of derivative financial instruments and other | 0 | 4,400 | (647,342) | 4,400 |
Total other income (expense) | (14,969) | (27,894) | (2,384,520) | (42,948) |
Loss before income taxes | (4,668,920) | (1,608,833) | (12,622,677) | (4,265,887) |
Provision for income taxes | 1,662 | 0 | 1,662 | 0 |
Net loss | (4,670,582) | (1,608,833) | (12,624,339) | (4,265,887) |
Preferred stock dividends | 0 | (175,246) | (244,508) | (458,799) |
Net loss available to common stockholders | $ (4,670,582) | $ (1,784,079) | $ (12,868,847) | $ (4,724,686) |
Net loss per common share - basic and diluted (in dollars per share) | $ (0.38) | $ (4.92) | $ (2) | $ (13.03) |
Weighted average shares outstanding - basic and diluted (in shares) | 12,261,238 | 362,537 | 6,444,373 | 362,537 |
Net loss | $ (4,670,582) | $ (1,608,833) | $ (12,624,339) | $ (4,265,887) |
Other comprehensive loss - foreign currency translation | (49) | 0 | (49) | 0 |
Comprehensive loss | $ (4,670,631) | $ (1,608,833) | $ (12,624,388) | $ (4,265,887) |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities | ||
Net loss | $ (12,624,339) | $ (4,265,887) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 392,404 | 461,432 |
Deferred tax provision | 1,662 | 0 |
Noncash interest expense | 1,598,312 | 20,883 |
Share-based compensation | 1,172,231 | 80,457 |
Inventory obsolescence | 0 | (44,595) |
Change in fair value of derivative financial instruments and other | 647,342 | (4,400) |
Changes in operating assets and liabilities, net of effects of acquisition: | ||
Accounts receivable | 507,066 | 62,251 |
Inventory | 288,126 | (159,174) |
All other assets | (306,386) | 78,311 |
Accounts payable | (814,855) | 29,853 |
Accrued compensation and other liabilities | (1,752,790) | (42,778) |
Deferred revenue | (180,311) | (121,551) |
Net cash used in operating activities | (11,071,538) | (3,905,198) |
Cash flows from investing activities | ||
Cash acquired in business combination | 1,367,211 | 0 |
Purchases of property and equipment | (89,234) | (39,537) |
Net cash provided by (used in) investing activities | 1,277,977 | (39,537) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 4,958,335 | 0 |
Proceeds from issuance of preferred stock, net of issuance costs | 0 | 1,937,902 |
Proceeds from issuance of convertible notes and warrants, net of issuance costs | 1,388,815 | 1,472,386 |
Proceeds from issuance of promissory notes, net of issuance costs | 1,741,667 | 0 |
Proceeds from exercise of stock options and warrants | 214 | 0 |
Proceeds from initial public offering, net of issuance costs paid in 2015 | 12,408,285 | 0 |
Payments on debt | (153,750) | (3,750) |
Payments on capital lease obligations | (112,200) | (80,575) |
Net cash provided by financing activities | 20,231,366 | 3,325,963 |
Effects of exchange rates on cash | (193) | 0 |
Net (decrease) increase in cash and cash equivalents | 10,437,612 | (618,772) |
Cash and cash equivalents at beginning of period | 749,517 | 1,400,345 |
Cash and cash equivalents at end of period | 11,187,129 | 781,573 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 201,233 | 26,088 |
Supplemental disclosure of noncash investing and financing activities: | ||
Acquisition of equipment purchased through capital leases | 429,320 | 0 |
Common stock issued in business combination | 2,584,090 | 0 |
Debt Conversion, Converted Instrument, Amount | 300,000 | 0 |
IPO [Member] | ||
Supplemental disclosure of noncash investing and financing activities: | ||
Debt Conversion, Converted Instrument, Amount | 2,100,000 | 0 |
Series A Preferred Stock [Member] | ||
Supplemental disclosure of noncash investing and financing activities: | ||
Debt Conversion, Converted Instrument, Amount | $ 3,000,000 | $ 0 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1 - Organization OpGen, Inc. (“OpGen”) was incorporated in Delaware in 2001. On July 14, 2015, OpGen completed the strategic acquisition (the “Merger”) of AdvanDx, Inc. and its wholly owned subsidiary AdvanDx A/S (collectively, “AdvanDx”) (see Note 4). Pursuant to the terms of a merger agreement, Velox Acquisition Corp. (OpGen’s wholly owned subsidiary formed for the express purpose of enacting the Merger) merged with and into AdvanDx, Inc. with AdvanDx, Inc. surviving as OpGen’s wholly owned subsidiary (see Note 4). OpGen, AdvanDx, Inc. and AdvanDx A/S are collectively referred to hereinafter as the “Company.” The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland and Woburn, Massachusetts. The Company also has operations in Copenhagen, Denmark. OpGen is an early-stage company using rapid molecular testing and bioinformatics to help guide antibiotic therapy and to assist healthcare providers to combat multi-drug resistant infections, or MDROs. OpGen’s lead products are its QuickFISH® and PNAFISH products, which are advanced in vitro The Company’s operations are subject to certain risks and uncertainties. The risks include rapid technology changes, the need to manage growth, the need to retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. The Company’s success depends, in part, on its ability to develop and commercialize its proprietary technology as well as raise additional capital. |
Liquidity and management's plan
Liquidity and management's plans | 9 Months Ended |
Sep. 30, 2015 | |
Liquidation Basis Of Accounting Abstract [Abstract] | |
Liquidity and management’s plans | Note 2 Liquidity and management’s plans The accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements. The Company raised significant funds in 2015, including: · $ 0.8 0.3 0.2 · $ 1.5 · $ 12.1 · $ 6.0 On May 8, 2015, OpGen completed its IPO pursuant to which it offered and sold 2,850,000 6.00 17.1 2.1 12.1 422,500 7,374,852 In July 2015, the Company raised $ 6.0 1,136,364 5.0 4.40 1.0 The Company’s current operating assumptions, which include management’s best estimate of future revenue and operating expenses, indicate that current cash on hand will be sufficient to fund operations through at least the end of the first quarter of 2016. In the event the Company is unable to successfully raise additional capital in 2016, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company would be compelled to reduce general and administrative expenses and delay research and development projects, including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing, or pursue other strategic alternatives which may include licensing and/or partnering arrangements or mergers and acquisitions. The financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence. |
Summary of significant accounti
Summary of significant accounting policies | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Note 3 - Summary of significant accounting policies The accompanying interim condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission, or SEC, for interim financial information. Accordingly, they do not include all the information and footnotes required by U.S. Generally Accepted Accounting Principles, or GAAP, for complete financial statements. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2014 previously filed with the SEC. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements included in the Company’s registration statement on Form S-1/A and, in the opinion of management, reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of September 30, 2015 and the results of operations and cash flows for the three and nine months ended September 30, 2015 and 2014. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2014 balance sheet included herein was derived from the audited financial statements, but may not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited interim condensed AdvanDx A/S is located in Copenhagen, Denmark and uses the Danish Krone as Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financial instruments, beneficial conversion features of convertible debt, deferred tax assets and liabilities and related valuation allowance, and depreciation and amortization and estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. All current assets and liabilities are carried at cost, which approximates fair value, because of the short-term maturities of those instrument s. The carrying value of the Company’s debt is The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $ 250,000 The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 45 79,697 At September 30, 2015, the Company had accounts receivable from two customers which individually represented 12 11 79 15 September 30, December 31, 2015 2014 Raw materials and supplies $ 697,414 $ 40,749 Work-in process 222,031 135,625 Finished goods 236,043 193,368 Total $ 1,155,488 $ 369,742 Inventories include the Argus Whole Genome Mapping Systems, reagents and supplies used for Argus consumable kits, reagents and components for QuickFISH and PNAFISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations 778,944 867,816 A warranty reserve is established upon the sale of any Argus System or Whole Genome Mapping product that is covered by warranty based on the estimated cost of replacement parts during the warranty period. Warranty periods are twelve months. The reserve is adjusted during the warranty period to reflect the remaining estimated costs under the warranty. The reserve for warranties was $ 2,750 Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and nine months ended September 30, 2015 and 2014, the Company determined that its property and equipment was not impaired. Intangible assets were acquired as part of the Merger, and consist of definite-lived intangible assets and goodwill. Definite-lived intangible assets Definite-lived intangible assets include trademarks, developed technology and customer relationships, and are amortized over their useful lives of 10 7 7 Goodwill Goodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is tax deductible in all relevant jurisdictions. As a result of the Merger, the Company recognized goodwill of approximately $ 292,000 The Company will conduct an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. All shares of Series A redeemable convertible preferred stock, or Series A Preferred Stock (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt (see Note 6)), were converted into 7,374,852 Prior to the IPO, the carrying value of the Series A Preferred Stock was increased by the accretion of related discounts, issuance costs and accrued but unpaid dividends so that the carrying amount would equal the redemption amount at the dates the stock becomes redeemable. At December 31, 2014, the Company had 3,999,864 70 The Company recognizes revenue primarily from sales of its products and services when the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred; the selling price is fixed or determinable; and collectability is reasonably assured. At times, the Company sells products and services, or performs software development, under multiple-element arrangements with separate units of accounting; in these situations, total consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. Amounts billed to customers for shipping and handling are included in revenue when the related product or service revenue is recognized. Shipping and handling costs are included in cost of sales. Revenue from sales of the Argus System When an Argus System is sold without the Genome Builder software, total arrangement consideration is recognized as revenue when the system is delivered to the customer. Ancillary performance obligations, including installation, limited customer training and limited consumables, are considered inconsequential and are combined with the Argus System as one unit of accounting. When an Argus System is sold with the Genome Builder software in a multiple-element arrangement, total arrangement consideration is allocated to the Argus System and to the Genome Builder software based on their relative selling prices. Selling prices are determined based on sales of similar systems to similar customers and, where no sales have occurred, on management’s best estimate of the expected selling price relative to similar products. Revenue related to the Argus System is recognized when it is delivered to the customer; revenue for the Genome Builder software is recognized when it is delivered to the customer. Revenue from sales of AdvanDx diagnostic products Revenue from sales of AdvanDx diagnostic products typically is recognized when the product is delivered to the customer. Revenue from sales of Genome Builder Software and consumables (on a stand-alone basis) Revenue is recognized for Genome Builder Software and for consumables, when sold on a standalone basis, upon delivery to the customer. Revenue from extended warranty service contracts The Company recognizes revenue associated with extended warranty service contracts over the service period in proportion to the costs expected to be incurred over that same period. Revenue from providing laboratory services The Company recognizes revenue associated with laboratory services contracts when the service has been performed and reports are made available to the customer. Revenue from funded software development arrangements The Company’s funded software development arrangements generally consist of multiple-elements. Total arrangement consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. When funded software development arrangements include substantive research and development milestones, revenue is recognized for each such milestone when the milestone is achieved and is due and collectible. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with achievement of the milestone. Share-based payments are recognized at fair value. The fair value of share-based payments to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. The Company’s tax provision for the three and nine months ended September 30, 2015 resulted from the deductibility of goodwill for tax purposes. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50 The Company had federal net operating loss, or NOL, carryforwards of $ 76,267,809 Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) restricted stock units (in 2014), (iii) stock purchase warrants, and (iv) prior to the IPO, convertible preferred stock and convertible debt, exercisable or exchangeable into common stock which have been excluded from the computation of diluted loss per share, was 5.7 6.1 In May 2014, the Financial Accounting Standards Board, or FASB, issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue arising from contracts with customers. The standard is effective for the Company’s reporting year beginning January 1, 2018 and early adoption is permitted starting January 1, 2017. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raise substantial doubt about the entity’s ability to continue as a going concern. The guidance 1) provides a definition for the term “substantial doubt,” 2) In April 2015, the FASB issued accounting guidance requiring that debt issuance costs related to a recognized liability be presented on the balance sheet as a direct reduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected. The standard is effective for reporting periods beginning after December 15, 2015. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. In July 2015, the FASB issued accounting guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidance at the lower of cost and net realizable value, except when inventory is measured using LIFO or the retail inventory method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASB has amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The standard is effective for reporting periods beginning after December 15, 2016. The amendments in this pronouncement should be applied prospectively, with earlier application permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. In September 2015, the FASB issued accounting guidance to simplify the accounting for measurement period adjustments resulting from business combinations. Under the guidance, an acquirer will be required to recognize adjustments to provisional amounts identified during the measurement period in the reporting period in which the adjustments are determined. The guidance requires an entity to present separately on the face of the income statement or disclose in the notes to the financial statements the portion of the amount recorded in current-period earnings by line item that would have been recorded in previous reporting periods if the adjustment had been recognized as of the acquisition date. The standard is effective for reporting periods beginning after December 15, 2015. The amendments in this pronouncement should be applied prospectively, with earlier application permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its results of operations, financial position, or cash flows. |
Business Combination
Business Combination | 9 Months Ended |
Sep. 30, 2015 | |
Business Combinations [Abstract] | |
Business Combination | Note 4 Business Combination On July 14, 2015, the Company completed the Merger by acquiring 100 in vitro Pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), Velox Acquisition Corp. merged with and into AdvanDx, Inc. with AdvanDx, Inc. surviving as a wholly owned subsidiary of the Company in accordance with the General Corporation Law of the State of Delaware. Under the terms of the Merger Agreement, the merger consideration consisted of an aggregate 681,818 2.6 The Company accounted for its acquisition of AdvanDx by recording all tangible and intangible assets acquired and liabilities assumed at their estimated fair values on the acquisition date, with the remaining unallocated purchase price recorded as goodwill. The fair value assigned to identifiable intangible assets acquired was determined using an income approach for trade names and customer relationships, and a cost approach for technology. The fair values are based on the Company’s estimates and may be adjusted from time to time, but no later than July 13, 2016, as better information becomes available. The Company received stepped-up bases in the acquired assets and liabilities and therefore did not recognize any deferred income tax assets and liabilities. Total purchase price - fair value of common stock issued $ 2,584,090 Fair value of tangible assets acquired: Cash 1,367,211 Receivables 557,112 Inventory 1,073,855 Property and equipment 250,636 Other assets 359,587 Fair value of identifiable intangible assets acquired: Customer relationships 1,094,000 Developed technology 458,000 Trademarks and tradenames 461,000 Fair value of goodwill 291,747 Fair value of liabilities assumed 3,329,058 $ 2,584,090 The total consideration paid in the acquisition exceeded the estimated fair value of the tangible and identifiable intangible assets acquired and liabilities assumed, resulting in approximately $ 0.3 0.5 0.8 0.8 Unaudited pro forma results Nine months ended Three months ended September 30, September 30, September 30, September 30, 2015 2014 2015 2014 Revenues $ 3,902,337 $ 6,631,510 $ 1,126,530 $ 1,955,894 Net loss $ (15,623,109) $ (11,784,997) $ (4,650,817) $ (4,517,541) Net loss per share $ (2.29) $ (11.72) $ (0.38) $ (4.49) |
Merck GHI Financing
Merck GHI Financing | 9 Months Ended |
Sep. 30, 2015 | |
Common Stock and Note Purchase Agreement [Abstract] | |
Common Stock and Note Purchase Agreement [Text Block] | Note 5 Merck GHI Financing On July 14, 2015, as a condition to the Merger, the Company entered into a Common Stock and Note Purchase Agreement (the “Purchase Agreement”) with Merck GHI, pursuant to which Merck GHI purchased 1,136,364 4.40 5.0 8 1.0 The Company incurred issuance costs of approximately $ 50,000 8,000 42,000 |
Fair value measurements
Fair value measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Note 6 - Fair value measurements The Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: · Level 1 - defined as observable inputs such as quoted prices in active markets; · Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and · Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions such as expected revenue growth and discount factors applied to cash flow projections. Financial assets and liabilities measured at fair value on a recurring basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. Fair value at September 30, 2015 Level 1 Level 2 Level 3 Cash and cash equivalents $ 11,187,129 $ 11,187,129 $ - $ - Fair value at December 31, 2014 Level 1 Level 2 Level 3 Cash and cash equivalents $ 749,517 $ 748,048 $ 1,469 $ - The Company’s Level 1 securities primarily consist of cash and cash equivalents, including money market funds and U.S. Treasury Notes; the Company determines the estimated fair value for its Level 1 securities using quoted (unadjusted) prices for identical assets or liabilities in active markets. Prior to its IPO, certain stock purchase warrants contained cash settlement features and, accordingly, the Company considered them to be derivative financial instruments and accounted for them at fair value using level 3 inputs. As a result of the Company’s IPO and elimination of the cash settlement features pursuant to their terms, those stock purchase warrants were reclassified to equity. For periods prior to the IPO, the Company determined the fair value of these derivative liabilities using a hybrid valuation method that consisted of a probability weighted expected return method that values the Company’s equity securities assuming various possible future economic outcomes while using an option pricing method (that treated all equity linked instruments as call options on the Company’s equity value with exercise prices based on the liquidation preference of the Series A Preferred Stock ) to estimate the allocation of value within one or more of the scenarios. Using this hybrid method, unobservable inputs included the Company’s equity value, the exercise price for each option value, expected timing of possible economic outcomes such as initial public offering, risk free interest rates and stock price volatility. Balance at Balance at December Established Change in Reclassified September Description 31, 2014 in 2015 Fair Value to Equity 30, 2015 Derivative warrant liability $ - $ 72,333 $ 647,342 $ (719,675) $ - Financial assets and liabilities carried at fair value on a non-recurring basis The Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis. Non-financial assets and liabilities carried at fair value on a recurring basis The Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis. Non-financial assets and liabilities carried at fair value on a non-recurring basis The Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurring basis when they are deemed to be impaired. No such fair value impairment was recognized in the three and nine month periods ended September 30, 2015 and 2014. See Note 4 for a discussion of the fair value of assets acquired and liabilities assumed in the Merger. |
Series A redeemable convertible
Series A redeemable convertible preferred stock | 9 Months Ended |
Sep. 30, 2015 | |
Preferred Stock, Number of Shares, Par Value and Other Disclosures [Abstract] | |
Series A redeemable convertible preferred stock | Note 7 Series A redeemable convertible preferred stock All shares of Series A Preferred Stock (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt (see Note 6)) were converted into 7,374,852 The Company issued 1,999,864 1.00 1,999,864 1,405,096 1,405,096 594,904 594,904 3,999,864 3,999,864 The holders of the Series A Preferred Stock had the right to receive non-cumulative dividends, at a rate of 8 two The holders of Series A Preferred Stock had the right to convert such shares, at their option and at any time, into shares of common stock at the then-applicable conversion rate, as defined. The initial conversion rate was one 70 three |
Debt
Debt | 9 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
Debt | Note 8 - Debt All the Company’s outstanding demand notes and convertible notes were exchanged for units in the Company’s IPO or otherwise were converted into Series A Preferred Stock and subsequently converted into shares of common stock in connection with the IPO. A short-term 8 150,000 1.0 8 1,001,250 Demand notes In the fourth quarter of 2014 and first quarter of 2015, the Company raised a total of $ 2.3 0.3 350,000 8 2014 convertible debt In July, August and September 2014, the Company raised $ 1.5 1,500,000 8 2015 convertible debt In February and March 2015, the Company raised $ 1.5 8 1,875,000 1.25 1.00 1.00 The conversion option embedded in the convertible notes was determined to contain beneficial conversion features, resulting in the bifurcation of those features as an equity instrument (resulting in an additional debt discount) at issuance. After allocation of the gross proceeds to the detachable stock purchase warrants (discussed below) and beneficial conversion feature, the total debt discount recognized was equal to the face value of the 2015 convertible notes. Upon conversion in May 2015, the remaining unamortized beneficial conversion feature of approximately $ 1.5 71,421 The 2015 convertible note holders also received detachable stock purchase warrants exercisable for 225,011 0.7 |
Stockholders' equity (deficit)
Stockholders' equity (deficit) | 9 Months Ended |
Sep. 30, 2015 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' equity (deficit) | Note 9 - Stockholders’ equity (deficit) On May 8, 2015, the Company completed its IPO pursuant to which the Company offered and sold 2,850,000 6.00 17.1 2.1 2.9 12.1 422,500 4,225 7,374,852 The stock purchase warrants issued as part of the units (including over-allotment option) are exercisable for 3,272,500 6.60 May 8, 2020 185,250 In July 2015, the Company issued 1,136,364 for cash consideration of $ 5.0 Stock options In 2002, the Company adopted the 2002 Stock Option and Restricted Stock Plan, or the 2002 Plan, pursuant to which the Company’s Board of Directors could grant either incentive stock options or non-qualified stock options, shares of restricted stock, shares of unrestricted common stock, and other share-based awards to officers and employees. In 2008, the Company adopted the 2008 Stock Option and Restricted Stock Plan, or the 2008 Plan, pursuant to which the Company’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultants and advisors. In April 2015, the Company adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan, or the 2015 Plan; the 2015 Plan became effective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no further grants will be made under the 2002 Plan or 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Internal Revenue Code to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for the grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors and consultants. Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 1,355,000 4 528,890 For the three months ended September 30, 2015 and 2014, the Company recorded $ 261,540 24,977 1,172,231 80,457 Three months ended September 30, 2015 2014 Research and development $ 59,688 $ 1,528 General and administrative 156,236 22,460 Sales and marketing 45,616 989 $ 261,540 $ 24,977 Nine months ended September 30, 2015 2014 Research and development $ 161,819 $ 3,903 General and administrative 443,267 74,032 Sales and marketing 567,145 2,522 $ 1,172,231 $ 80,457 During the nine months ended September 30, 2015, the Company granted stock options to acquire 1,660,387 2.87 3.16 1,948,249 Restricted stock units In March 2014, the Company awarded restricted stock units to acquire 130,640 130,640 Stock purchase warrants The Company has total stock purchase warrants to acquire 3,716,355 33,594 225,011 3,457,750 |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Note 10 - Commitments and contingencies Operating leases During the second quarter 2015, the Company extended the term of its Gaithersburg, Maryland office lease, effective May 7, 2015, through January 31, 2021, with one additional five-year renewal at the Company’s election. The Company is responsible for all utilities, repairs, insurance, and taxes under this operating lease. Effective July 1, 2015, the Company further modified its lease agreement to add additional leased space to its headquarters. 447,007 341,862 Capital leases The Company leases computer equipment, office furniture, and equipment under various capital leases. The leases expire at various dates through 2018. The leases require monthly principal and interest payments. Registration and other shareholder rights In connection with the Merger and the investment transactions (see Notes 4 and 5), the Company also entered into a Registration Rights Agreement with the AdvanDx stockholders receiving Merger Consideration and with Merck GHI, pursuant to which the investors were granted certain demand registration rights and piggyback registration rights in connection with subsequent registered offerings of the Company's common stock. Merck GHI also received rights to participate on a pro-rata basis in future securities offerings by the Company. On December 18, 2013, the Company entered into the Third Amended and Restated Investors' Rights Agreement (the "Investors' Rights Agreement") with investors acquiring promissory notes convertible into shares of the Company's Series A Preferred Stock. Following the IPO, the holders of 20% or more of the securities subject to the Investors' Rights Agreement have demand registration rights and piggyback registration rights in connection with subsequent registered offerings of the Company's common stock. |
License agreements, research co
License agreements, research collaborations and development agreements | 9 Months Ended |
Sep. 30, 2015 | |
License Agreements Research Collaborations And Development Agreements [Abstract] | |
License agreements, research collaborations and development agreements | Note 11 - License agreements, research collaborations and development agreements OpGen is a party to two license agreements to acquire certain patent rights and technologies. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. Certain of the agreements require the Company to pay minimum royalties or license maintenance fees. The Company recognized $ 7,484 23,810 ($13,769) 73,142 20,000 In September 2013, OpGen entered into a technology development agreement in which the Company would receive fixed milestone payments for meeting development milestones under the agreement. Since the milestones are substantive, the Company recognizes revenue in the periods in which the substantive milestones are achieved; the Company attained sixteen milestones during 2014. In addition, the Company received an upfront payment of $ 250,000 208,340 1,133,340 27,780 172,220 In July 2003, AdvanDx entered into a non-exclusive, non-sublicensable, worldwide license agreement with Life Technologies, Inc. (“Life Technologies”) to use certain patent rights that allow it to manufacture and sell certain products. The agreement was amended multiple times through 2009 to add additional features and modify certain terms and conditions. Life Technologies is entitled to certain royalties on product sales. The Company expensed royalties of $ 150,570 |
Related party transactions
Related party transactions | 9 Months Ended |
Sep. 30, 2015 | |
Related Party Transactions [Abstract] | |
Related party transactions | Note 12 - Related party transactions In March 2014, the Company entered into a supply agreement with Fluidigm Corporation, or Fluidigm, under which Fluidigm supplies the Company with its microfluidic test platform for use in manufacturing the Acuitas MDRO Gene Test. The Company’s CEO and Chairman of the Board of Directors of the Company, is a director of Fluidigm. On July 12, 2015, the Company entered into a letter agreement, or the Agreement, with Fluidigm to expand the companies' existing relationship to include collaborating on the development of test kits and custom analytic instruments for identification, screening and surveillance testing of MDROs. The Agreement also expands the existing Supply Agreement between the Company and Fluidigm, and provides for expansion of the gene targets and organisms to be tested on the Company's existing CLIA lab-based tests, the Acuitas MDRO Gene Test and the Acuitas Resistome Test, using Fluidigm technologies and products. Additionally, Fluidigm has agreed not to develop or directly collaborate with any third party to develop an FDA approved or CE marked diagnostic tests for the purpose of detecting resistome genes for identified MDROs if the Company meets certain minimum purchase commitments and other requirements. The initial term of the Agreement is five years. Both parties have the ability to extend the term for an additional five years. Under the expanded Supply Agreement, the term is extended until March 17, 2018, and the Company has the right to extend the term of the Supply Agreement for up to two additional three-year terms. |
Summary of significant accoun18
Summary of significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation and consolidation The accompanying interim condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission, or SEC, for interim financial information. Accordingly, they do not include all the information and footnotes required by U.S. Generally Accepted Accounting Principles, or GAAP, for complete financial statements. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2014 previously filed with the SEC. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements included in the Company’s registration statement on Form S-1/A and, in the opinion of management, reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of September 30, 2015 and the results of operations and cash flows for the three and nine months ended September 30, 2015 and 2014. The interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2014 balance sheet included herein was derived from the audited financial statements, but may not include all disclosures including notes required by GAAP for complete financial statements. The accompanying unaudited interim condensed |
Foreign Currency | Foreign Currency AdvanDx A/S is located in Copenhagen, Denmark and uses the Danish Krone as Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts in the foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar. |
Use of estimates | Use of estimates In preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimates are used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financial instruments, beneficial conversion features of convertible debt, deferred tax assets and liabilities and related valuation allowance, and depreciation and amortization and estimated useful lives of long-lived assets, and the recoverability of long-lived assets. Actual results could differ from those estimates. |
Fair value of financial instruments | Fair value of financial instruments All current assets and liabilities are carried at cost, which approximates fair value, because of the short-term maturities of those instrument s. The carrying value of the Company’s debt is |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cash equivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $ 250,000 |
Accounts receivable | Accounts receivable The Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’s financial condition and, generally, collateral is not required. Accounts receivable are due within 30 45 79,697 At September 30, 2015, the Company had accounts receivable from two customers which individually represented 12 11 79 15 |
Inventories | Inventories September 30, December 31, 2015 2014 Raw materials and supplies $ 697,414 $ 40,749 Work-in process 222,031 135,625 Finished goods 236,043 193,368 Total $ 1,155,488 $ 369,742 Inventories include the Argus Whole Genome Mapping Systems, reagents and supplies used for Argus consumable kits, reagents and components for QuickFISH and PNAFISH kit products, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations 778,944 867,816 |
Product warranty | Product warranty A warranty reserve is established upon the sale of any Argus System or Whole Genome Mapping product that is covered by warranty based on the estimated cost of replacement parts during the warranty period. Warranty periods are twelve months. The reserve is adjusted during the warranty period to reflect the remaining estimated costs under the warranty. The reserve for warranties was $ 2,750 |
Impairment of long-lived assets | Impairment of property and equipment Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets. During the three and nine months ended September 30, 2015 and 2014, the Company determined that its property and equipment was not impaired. |
Intangible assets and goodwill | Intangible assets and goodwill Intangible assets were acquired as part of the Merger, and consist of definite-lived intangible assets and goodwill. Definite-lived intangible assets Definite-lived intangible assets include trademarks, developed technology and customer relationships, and are amortized over their useful lives of 10 7 7 Goodwill Goodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities. Goodwill is tax deductible in all relevant jurisdictions. As a result of the Merger, the Company recognized goodwill of approximately $ 292,000 The Company will conduct an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. |
Redeemable convertible preferred stock | Redeemable convertible preferred stock All shares of Series A redeemable convertible preferred stock, or Series A Preferred Stock (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt (see Note 6)), were converted into 7,374,852 Prior to the IPO, the carrying value of the Series A Preferred Stock was increased by the accretion of related discounts, issuance costs and accrued but unpaid dividends so that the carrying amount would equal the redemption amount at the dates the stock becomes redeemable. At December 31, 2014, the Company had 3,999,864 70 |
Revenue recognition | Revenue recognition The Company recognizes revenue primarily from sales of its products and services when the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred; the selling price is fixed or determinable; and collectability is reasonably assured. At times, the Company sells products and services, or performs software development, under multiple-element arrangements with separate units of accounting; in these situations, total consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. Amounts billed to customers for shipping and handling are included in revenue when the related product or service revenue is recognized. Shipping and handling costs are included in cost of sales. Revenue from sales of the Argus System When an Argus System is sold without the Genome Builder software, total arrangement consideration is recognized as revenue when the system is delivered to the customer. Ancillary performance obligations, including installation, limited customer training and limited consumables, are considered inconsequential and are combined with the Argus System as one unit of accounting. When an Argus System is sold with the Genome Builder software in a multiple-element arrangement, total arrangement consideration is allocated to the Argus System and to the Genome Builder software based on their relative selling prices. Selling prices are determined based on sales of similar systems to similar customers and, where no sales have occurred, on management’s best estimate of the expected selling price relative to similar products. Revenue related to the Argus System is recognized when it is delivered to the customer; revenue for the Genome Builder software is recognized when it is delivered to the customer. Revenue from sales of AdvanDx diagnostic products Revenue from sales of AdvanDx diagnostic products typically is recognized when the product is delivered to the customer. Revenue from sales of Genome Builder Software and consumables (on a stand-alone basis) Revenue is recognized for Genome Builder Software and for consumables, when sold on a standalone basis, upon delivery to the customer. Revenue from extended warranty service contracts The Company recognizes revenue associated with extended warranty service contracts over the service period in proportion to the costs expected to be incurred over that same period. Revenue from providing laboratory services The Company recognizes revenue associated with laboratory services contracts when the service has been performed and reports are made available to the customer. Revenue from funded software development arrangements The Company’s funded software development arrangements generally consist of multiple-elements. Total arrangement consideration is allocated to the identified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. When funded software development arrangements include substantive research and development milestones, revenue is recognized for each such milestone when the milestone is achieved and is due and collectible. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with achievement of the milestone. |
Share-based compensation | Share-based compensation Share-based payments are recognized at fair value. The fair value of share-based payments to employees and directors is estimated, on the date of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. |
Income taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future tax consequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected to be realized. The Company’s tax provision for the three and nine months ended September 30, 2015 resulted from the deductibility of goodwill for tax purposes. Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50 The Company had federal net operating loss, or NOL, carryforwards of $ 76,267,809 |
Loss per share | Loss per share Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of shares of common stock outstanding during the period. For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-converted method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) restricted stock units (in 2014), (iii) stock purchase warrants, and (iv) prior to the IPO, convertible preferred stock and convertible debt, exercisable or exchangeable into common stock which have been excluded from the computation of diluted loss per share, was 5.7 6.1 |
Recent accounting pronouncements | Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued guidance for revenue recognition for contracts, superseding the previous revenue recognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identify the contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The new standard will result in enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue arising from contracts with customers. The standard is effective for the Company’s reporting year beginning January 1, 2018 and early adoption is permitted starting January 1, 2017. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raise substantial doubt about the entity’s ability to continue as a going concern. The guidance 1) provides a definition for the term “substantial doubt,” 2) In April 2015, the FASB issued accounting guidance requiring that debt issuance costs related to a recognized liability be presented on the balance sheet as a direct reduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected. The standard is effective for reporting periods beginning after December 15, 2015. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. In July 2015, the FASB issued accounting guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidance at the lower of cost and net realizable value, except when inventory is measured using LIFO or the retail inventory method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASB has amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The standard is effective for reporting periods beginning after December 15, 2016. The amendments in this pronouncement should be applied prospectively, with earlier application permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. In September 2015, the FASB issued accounting guidance to simplify the accounting for measurement period adjustments resulting from business combinations. Under the guidance, an acquirer will be required to recognize adjustments to provisional amounts identified during the measurement period in the reporting period in which the adjustments are determined. The guidance requires an entity to present separately on the face of the income statement or disclose in the notes to the financial statements the portion of the amount recorded in current-period earnings by line item that would have been recorded in previous reporting periods if the adjustment had been recognized as of the acquisition date. The standard is effective for reporting periods beginning after December 15, 2015. The amendments in this pronouncement should be applied prospectively, with earlier application permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financial statements. The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have a material impact on its results of operations, financial position, or cash flows. |
Summary of significant accoun19
Summary of significant accounting policies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Schedule of inventories | Inventories are valued using the first-in, first-out method and stated at the lower of cost or market and consist of the following: September 30, December 31, 2015 2014 Raw materials and supplies $ 697,414 $ 40,749 Work-in process 222,031 135,625 Finished goods 236,043 193,368 Total $ 1,155,488 $ 369,742 |
Business Combination (Tables)
Business Combination (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Business Combinations [Abstract] | |
Schedule of preliminary allocation of the purchase price | The following represents the preliminary allocation of the purchase price: Total purchase price - fair value of common stock issued $ 2,584,090 Fair value of tangible assets acquired: Cash 1,367,211 Receivables 557,112 Inventory 1,073,855 Property and equipment 250,636 Other assets 359,587 Fair value of identifiable intangible assets acquired: Customer relationships 1,094,000 Developed technology 458,000 Trademarks and tradenames 461,000 Fair value of goodwill 291,747 Fair value of liabilities assumed 3,329,058 $ 2,584,090 |
Schedule of unaudited pro forma financial information | The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the Merger had been completed as of January 1, 2014. Pro forma information primarily reflects adjustments relating to (i) elimination of the interest on AdvanDx’s outstanding debt, and (ii) the amortization of intangibles acquired. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2014 or that may be obtained in the future: Unaudited pro forma results Nine months ended Three months ended September 30, September 30, September 30, September 30, 2015 2014 2015 2014 Revenues $ 3,902,337 $ 6,631,510 $ 1,126,530 $ 1,955,894 Net loss $ (15,623,109) $ (11,784,997) $ (4,650,817) $ (4,517,541) Net loss per share $ (2.29) $ (11.72) $ (0.38) $ (4.49) |
Fair value measurements (Tables
Fair value measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | The following tables present the fair value hierarchy for the Company’s financial assets and liabilities measured at fair value on a recurring basis at September 30, 2015 and December 31, 2014: Fair value at September 30, 2015 Level 1 Level 2 Level 3 Cash and cash equivalents $ 11,187,129 $ 11,187,129 $ - $ - Fair value at December 31, 2014 Level 1 Level 2 Level 3 Cash and cash equivalents $ 749,517 $ 748,048 $ 1,469 $ - |
Summary of change in fair value classified as Level 3 liabilities measured at fair value on a recurring basis | The following tables set forth a summary of changes in the fair value of Level 3 liabilities measured at fair value on a recurring basis for the nine months ended September 30, 2015: Balance at Balance at December Established Change in Reclassified September Description 31, 2014 in 2015 Fair Value to Equity 30, 2015 Derivative warrant liability $ - $ 72,333 $ 647,342 $ (719,675) $ - |
Stockholders' equity (deficit)
Stockholders' equity (deficit) (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Stockholders' Equity Note [Abstract] | |
Schedule of allocation of share-based compensation expense | The allocation of share-based compensation expense by operating expenses is as follows: Three months ended September 30, 2015 2014 Research and development $ 59,688 $ 1,528 General and administrative 156,236 22,460 Sales and marketing 45,616 989 $ 261,540 $ 24,977 Nine months ended September 30, 2015 2014 Research and development $ 161,819 $ 3,903 General and administrative 443,267 74,032 Sales and marketing 567,145 2,522 $ 1,172,231 $ 80,457 |
Liquidity and management's pl23
Liquidity and management's plans (Details Textual) - USD ($) | Jul. 14, 2015 | May. 08, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 |
Conversion of Stock [Line Items] | |||||||
Proceeds from Notes Payable | $ 1,741,667 | $ 0 | |||||
Stock And Warrants Issued During Period Shares Initial Public Offering | 2,850,000 | ||||||
Stock And Warrants Issued During Period Shares Initial Public Offering Purchase Price Per Unit | $ 6 | ||||||
Proceeds From Issuance Of Units Under Initial Public Offering Gross | $ 17,100,000 | ||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | 12,100,000 | ||||||
Debt Conversion, Original Debt, Amount | $ 2,100,000 | ||||||
Conversion of Stock, Shares Issued | 7,374,852 | ||||||
Proceeds from Issuance of Common Stock | 4,958,335 | 0 | |||||
Debt Conversion, Converted Instrument, Amount | 300,000 | 0 | |||||
Merck Global Health Innovation Fund LLC | AdvanDx Inc [Member] | |||||||
Conversion of Stock [Line Items] | |||||||
Proceeds From Issuance Of Shares And Debt | $ 6,000,000 | ||||||
Common Stock | |||||||
Conversion of Stock [Line Items] | |||||||
Stock And Warrants Issued During Period Shares Initial Public Offering | 422,500 | ||||||
Proceeds From Issuance Of Units Under Initial Public Offering Gross | $ 17,100,000 | ||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | 12,100,000 | ||||||
Common Stock | Merck Global Health Innovation Fund LLC | |||||||
Conversion of Stock [Line Items] | |||||||
Sale of Stock, Price Per Share | $ 4.40 | ||||||
Sale of Stock, Number of Shares Issued in Transaction | 1,136,364 | ||||||
Proceeds from Issuance of Common Stock | $ 5,000,000 | ||||||
Initial public offering | |||||||
Conversion of Stock [Line Items] | |||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | $ 12,100,000 | ||||||
Debt Conversion, Converted Instrument, Amount | 2,100,000 | $ 0 | |||||
Convertible Notes Payable | |||||||
Conversion of Stock [Line Items] | |||||||
Proceeds from Convertible Debt | 1,500,000 | ||||||
Short-term Demand Notes | |||||||
Conversion of Stock [Line Items] | |||||||
Proceeds from Notes Payable | $ 2,300,000 | 800,000 | |||||
Repayments of Notes Payable | $ 200,000 | ||||||
Debt Conversion, Converted Instrument, Amount | $ 300,000 | ||||||
Promissory Note | Merck Global Health Innovation Fund LLC | |||||||
Conversion of Stock [Line Items] | |||||||
Debt Instrument, Face Amount | $ 1,000,000 | ||||||
Promissory Note | Common Stock | Merck Global Health Innovation Fund LLC | |||||||
Conversion of Stock [Line Items] | |||||||
Proceeds From Issuance Of Common Stock And Notes Payable | $ 6,000,000 |
Summary of significant accoun24
Summary of significant accounting policies (Details) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Inventories | ||
Raw materials and supplies | $ 697,414 | $ 40,749 |
Work-in process | 222,031 | 135,625 |
Finished goods | 236,043 | 193,368 |
Total | $ 1,155,488 | $ 369,742 |
Summary of significant accoun25
Summary of significant accounting policies (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | Jun. 30, 2015 | May. 08, 2015 | |
Significant Accounting Policies [Line Items] | |||||||
Allowance for Doubtful Accounts Receivable | $ 79,697 | $ 79,697 | $ 79,697 | ||||
Inventory Valuation Reserves | $ 778,944 | $ 778,944 | 867,816 | ||||
Operating Loss Carryforwards | 76,267,809 | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,700,000 | 6,100,000 | 5,700,000 | 6,100,000 | |||
Cash, FDIC Insured Amount | $ 250,000 | $ 250,000 | |||||
Product Warranty Accrual | 2,750 | 2,750 | 2,750 | ||||
Goodwill | $ 291,747 | $ 291,747 | $ 0 | ||||
Developed Technology Rights [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Finite-Lived Intangible Asset, Useful Life | 7 years | ||||||
Customer Relationships [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Finite-Lived Intangible Asset, Useful Life | 7 years | ||||||
Trademarks [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||||||
Common Stock [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 7,374,852 | 7,374,852 | |||||
Series A Convertible Redeemable Preferred Stock | |||||||
Significant Accounting Policies [Line Items] | |||||||
Temporary Equity Redemption Request Of Minimum Percentage Of Holders Of Outstanding Preferred Stock Required | 70.00% | ||||||
Temporary Equity, Shares Outstanding | 0 | 0 | 3,999,864 | ||||
Accounts Receivable | Customer One | |||||||
Significant Accounting Policies [Line Items] | |||||||
Concentration Risk, Percentage | 12.00% | 79.00% | |||||
Accounts Receivable | Customer Two | |||||||
Significant Accounting Policies [Line Items] | |||||||
Concentration Risk, Percentage | 11.00% | 15.00% | |||||
Maximum | |||||||
Significant Accounting Policies [Line Items] | |||||||
Accounts Receivable Period Due | 45 days | ||||||
Minimum | |||||||
Significant Accounting Policies [Line Items] | |||||||
Accounts Receivable Period Due | 30 days |
Business Combination (Details)
Business Combination (Details) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Fair value of identifiable intangible assets acquired: | ||
Fair value of goodwill | $ 291,747 | $ 0 |
AdvanDx [Member] | ||
Business Acquisition [Line Items] | ||
Total purchase price - fair value of common stock issued | 2,584,090 | |
Fair value of tangible assets acquired: | ||
Cash | 1,367,211 | |
Receivables | 557,112 | |
Inventory | 1,073,855 | |
Property and equipment | 250,636 | |
Other assets | 359,587 | |
Fair value of identifiable intangible assets acquired: | ||
Customer relationships | 1,094,000 | |
Developed technology | 458,000 | |
Trademarks and tradenames | 461,000 | |
Fair value of goodwill | 291,747 | |
Fair value of liabilities assumed | 3,329,058 | |
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Net, Total | $ 2,584,090 |
Business Combination (Details 1
Business Combination (Details 1) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Business Acquisition, Pro Forma Information | ||||
Revenues | $ 1,126,530 | $ 1,955,894 | $ 3,902,337 | $ 6,631,510 |
Net loss | $ (4,650,817) | $ (4,517,541) | $ (15,623,109) | $ (11,784,997) |
Net loss per share | $ (0.38) | $ (4.49) | $ (2.29) | $ (11.72) |
Business Combination (Details T
Business Combination (Details Textual) - USD ($) | Jul. 14, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 |
Business Acquisition [Line Items] | ||||||
Business Acquisition, Percentage of Voting Interests Acquired | 100.00% | |||||
Goodwill | $ 291,747 | $ 291,747 | $ 0 | |||
Payments of Merger Related Costs, Financing Activities | 500,000 | |||||
Revenues, Total | 980,786 | $ 834,824 | 1,828,133 | $ 3,004,246 | ||
Net Income (Loss) Attributable to Parent | (4,670,582) | $ (1,608,833) | (12,624,339) | $ (4,265,887) | ||
AdvanDx [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Goodwill | $ 291,747 | 291,747 | ||||
Revenues, Total | 800,000 | |||||
Net Income (Loss) Attributable to Parent | $ 800,000 | |||||
AdvanDx [Member] | Equity Issued in Business Combination [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Stock Issued During Period Shares for Meger | 681,818 | |||||
Shareholders' Equity, Fair Value Disclosure | $ 2,600,000 |
Merck GHI Financing (Details Te
Merck GHI Financing (Details Textual) - USD ($) | Jul. 14, 2015 | Sep. 30, 2015 | Sep. 30, 2014 |
Common Stock and Note Purchase Agreement [Line Items] | |||
Proceeds from Issuance of Common Stock | $ 4,958,335 | $ 0 | |
Merck GHI Financing Agreement [Member] | |||
Common Stock and Note Purchase Agreement [Line Items] | |||
Sale of Stock, Number of Shares Issued in Transaction | 1,136,364 | ||
Shares Issued, Price Per Share | $ 4.40 | ||
Proceeds from Issuance of Common Stock | $ 5,000,000 | ||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | ||
Debt Instrument, Face Amount | $ 1,000,000 | ||
Fees Related to Common Stock and Debt Transaction | 50,000 | ||
Payments of Debt Issuance Costs | 8,000 | ||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 42,000 |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Fair value measurements on recurring basis | ||
Cash and cash equivalents | $ 11,187,129 | $ 749,517 |
Level 1 | ||
Fair value measurements on recurring basis | ||
Cash and cash equivalents | 11,187,129 | 748,048 |
Level 2 | ||
Fair value measurements on recurring basis | ||
Cash and cash equivalents | 0 | 1,469 |
Level 3 | ||
Fair value measurements on recurring basis | ||
Cash and cash equivalents | $ 0 | $ 0 |
Fair value measurements (Deta31
Fair value measurements (Details 1) - Warrant | 9 Months Ended |
Sep. 30, 2015USD ($) | |
Changes in the fair value of Level 3 liabilities measured at fair value on recurring basis | |
Balance at the begining of the period | $ 0 |
Established in 2015 | 72,333 |
Change in Fair Value | 647,342 |
Reclassifed to Equity | (719,675) |
Balance at the end of the period | $ 0 |
Series A redeemable convertib32
Series A redeemable convertible preferred stock (Details Textual) - USD ($) | May. 08, 2015 | Apr. 30, 2014 | Feb. 28, 2014 | Dec. 31, 2013 | Sep. 30, 2015 | Dec. 31, 2014 |
Class of Stock [Line Items] | ||||||
Debt Conversion, Original Debt, Amount | $ 2,100,000 | |||||
Conversion of Stock, Shares Issued | 7,374,852 | |||||
Series A Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Temporary Equity, Shares Issued | 594,904 | 1,405,096 | 1,999,864 | |||
Temporary Equity, Par or Stated Value Per Share | $ 1 | |||||
Debt Conversion, Original Debt, Amount | $ 1,999,864 | |||||
Proceeds from Issuance of Convertible Preferred Stock | $ 594,904 | $ 1,405,096 | ||||
Temporary Equity, Shares Outstanding | 3,999,864 | |||||
Temporary Equity Shares Outstanding Convertible Into Common Stock Number | 3,999,864 | |||||
Preferred Stock, Dividend Rate, Percentage | 8.00% | |||||
Temporary Equity Liquidation And Redemption Preference Multiple Of Purchase Price | 2 | |||||
Conversion of Stock, Shares Issued | 1 | |||||
Temporary Equity Redemption Request Of Minimum Percentage Of Holders Of Outstanding Preferred Stock Required | 70.00% | |||||
Temporary Equity Redemption Number Of Installments | 3 | |||||
Debt Conversion, Converted Instrument, Shares Issued | 7,374,852 |
Debt (Details Textual)
Debt (Details Textual) | May. 08, 2015USD ($) | Jul. 31, 2015USD ($) | May. 31, 2015USD ($)shares | Mar. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2014USD ($) | Mar. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) |
Debt Instrument [Line Items] | |||||||||||
Proceeds from Notes Payable | $ 1,741,667 | $ 0 | |||||||||
Debt Conversion, Converted Instrument, Amount | 300,000 | 0 | |||||||||
Fair Value Adjustment of Warrants | $ 700,000 | $ 0 | $ (4,400) | 647,342 | (4,400) | ||||||
Interest Expense, Debt | $ 1,500,000 | 1,500,000 | |||||||||
Amortization of Financing Costs | 71,421 | ||||||||||
Common Stock Percent | 8.00% | 8.00% | 8.00% | ||||||||
Common Stock [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 225,011 | 225,011 | 225,011 | ||||||||
IPO [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Conversion, Converted Instrument, Amount | 2,100,000 | $ 0 | |||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 1,875,000 | ||||||||||
IPO [Member] | Common Stock [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 350,000 | ||||||||||
2014 Convertible Notes | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | 8.00% | |||||||||
Proceeds from Other Short-term Debt | $ 1,500,000 | ||||||||||
2015 Convertible Notes | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | 8.00% | 0.00% | 8.00% | 8.00% | ||||||
Proceeds from Other Short-term Debt | $ 1,000,000 | $ 1,500,000 | $ 150,000 | ||||||||
Convertible Notes Payable | $ 1,001,250 | 1,001,250 | |||||||||
2015 Convertible Notes | Common Stock [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Instrument, Convertible, Conversion Price | $ / shares | $ 1 | $ 1 | $ 1 | ||||||||
2015 Convertible Notes | Pre IPO | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Instrument, Convertible, Conversion Ratio | 1.25 | ||||||||||
2015 Convertible Notes | Post IPO | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt Instrument, Convertible, Conversion Ratio | 1 | ||||||||||
Short-term Demand Notes | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from Notes Payable | $ 2,300,000 | $ 800,000 | |||||||||
Debt Conversion, Converted Instrument, Amount | $ 300,000 | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.00% | 8.00% |
Stockholders' equity (deficit34
Stockholders' equity (deficit) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | $ 261,540 | $ 24,977 | $ 1,172,231 | $ 80,457 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 59,688 | 1,528 | 161,819 | 3,903 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | 156,236 | 22,460 | 443,267 | 74,032 |
Sales and marketing activities | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share-based compensation expense | $ 45,616 | $ 989 | $ 567,145 | $ 2,522 |
Stockholders' equity (deficit35
Stockholders' equity (deficit) (Details Textual) - USD ($) | Jul. 14, 2015 | May. 08, 2015 | Jul. 31, 2015 | Oct. 24, 2014 | Mar. 31, 2014 | Sep. 30, 2015 | Jun. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Mar. 31, 2015 | Dec. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Allocated Share-based Compensation Expense | $ 261,540 | $ 24,977 | $ 1,172,231 | $ 80,457 | ||||||||
Debt Conversion, Converted Instrument, Amount | 300,000 | 0 | ||||||||||
Stock Purchase Warrants Issued Upon Conversion Over Allotment Option | 422,500 | |||||||||||
Proceeds from Issuance of Warrants | $ 4,225 | |||||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Gross | 17,100,000 | |||||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | $ 12,100,000 | |||||||||||
Stock Issued During Period, Value, Acquisitions | $ 2,584,090 | 0 | ||||||||||
Merck Global Health Innovation Fund LLC [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Shares, New Issues | 1,136,364 | |||||||||||
Over-Allotment Option [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,272,500 | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.60 | |||||||||||
Expiration Date of Warrants Issued | May 8, 2020 | |||||||||||
Demand Notes Payable [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Debt Conversion, Converted Instrument, Amount | $ 2,100,000 | |||||||||||
2015 Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,355,000 | 1,355,000 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 528,890 | 528,890 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Common stock Pecentage | 4.00% | |||||||||||
Stock Purchase Warrants Issued | 3,457,750 | |||||||||||
Stock options | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Allocated Share-based Compensation Expense | $ 261,540 | $ 24,977 | $ 1,172,231 | $ 80,457 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 1,660,387 | |||||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 2.87 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 3.16 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 1,948,249 | 1,948,249 | ||||||||||
Restricted stock units | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | 130,640 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period | 130,640 | |||||||||||
Warrant | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Class of Warrant or Right, Outstanding | 3,716,355 | 3,716,355 | 33,594 | |||||||||
Common Stock [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock and Warrants Issued in Conjunction with Initial Public Offering | 2,850,000 | |||||||||||
Offering Price Per Unit | $ 6 | |||||||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 2,900,000 | |||||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 7,374,852 | 7,374,852 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 225,011 | |||||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Gross | $ 17,100,000 | |||||||||||
Proceeds From Issuance Of Units Under Initial Public Offering Net | $ 12,100,000 | |||||||||||
Common Stock [Member] | Merck Global Health Innovation Fund LLC [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock Issued During Period, Value, Acquisitions | $ 5,000,000 | |||||||||||
Common Stock [Member] | Over-Allotment Option [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 185,250 |
Commitments and contingencies (
Commitments and contingencies (Details Textual) - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Operating Leased Assets [Line Items] | ||
Operating Leases, Rent Expense, Net | $ 447,007 | $ 341,862 |
License agreements, research 37
License agreements, research collaborations and development agreements (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2013 | Sep. 30, 2015 | Sep. 30, 2014 | Jun. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Future Minimum Royalty Payments Due | $ 20,000 | $ 20,000 | ||||
License Upfront Payment Received | $ 250,000 | |||||
Royalty (Income) Expense | 7,484 | $ 23,810 | (13,769) | $ 73,142 | ||
Licenses Revenue | 27,780 | $ 172,220 | $ 208,340 | $ 1,133,340 | ||
Life Technologies [Member] | ||||||
License Agreements Research Collaborations And Development Agreements [Line Items] | ||||||
Royalty (Income) Expense | $ 150,570 |